Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513312
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis PrEP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open-label Multicenter Randomized Study to Evaluate the Persistence Safety Acceptability and Pharmacokinetics of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis PrEP in People Who Would Benefit From PrEP
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PURPOSE 5
Brief Summary:
The goals of this clinical study are to learn more about the study drug lenacapavir LEN by comparing the consistent and continuous use of LEN and emtricitabinetenofovir disoproxil fumarate coformulated Truvada FTDF then by observing the safety of LEN and FTDF evaluating the acceptability of LEN injections and oral FTDF and observe how LEN moves throughout the body in people who would benefit from pre-exposure prophylaxis PrEP
The primary objective of this study is to compare LEN and FTDF consistent and continuous use among people who would benefit from PrEP
The primary objective of this study is to compare LEN and FTDF consistent and continuous use among people who would benefit from PrEP
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None